Issue link: https://industrialengineer.epubxp.com/i/920036
January 2018 | ISE Magazine 35 safety consequence of failing to achieve an appropriate degree of precision. The economics associated with achieving greater specificity, while rel- evant from a business standpoint, are secondary with respect to GMP. Good manufacturing practice requires that the physical specifications shall be sufficient to achieve the intended technical effect, ultimately ensuring the safety of the fin- ished packaging material and food. Similarly, compliance with chemical specifications directly affects the nature and quality of the finished food-contact material. For example, adding insuf- ficient amounts of a catalyst, additive or processing aid may result in a mate- rial that fails to meet certain physical requirements (the bottle may appear hazy, may feel tacky or may not be rigid enough). Conversely, adding too much of a substance may result in a product that imparts an off-taste or odor to food, resulting in adulteration of the food, per se, under the act. Here again, the FDA's requirements with respect to good manufacturing practice do not specify the degree to which a company must meet chemical tolerance requirements, recognizing that such determinations must be made on a case-by-case basis. Rather, the FDA's GMP requirements specify that the company take sufficient steps to en- sure that the finished material or article is suitably pure for the intended use. Operations management and auditing strategies The FDA's good manufacturing prac- tice requirements obligate companies to demonstrate that the production process is sufficiently designed, implemented and effectively managed to ensure that the finished material is safe and suitable when used as intended. Decisions about design, planning, production and in- spection must ensure that a material is produced consistently, safely and in ac- cordance with the FDA's requirements. Therefore, a robust production process should incorporate written operating procedures and auditing strategies as part of an overall good manufacturing practice and quality plan. Written operating procedures, often referred to as standard operating pro- cedures (SOPs), serve as a foundation for the production process and preserve and convey consistent instructions to staff and management. Ideally, SOPs should be developed before production starts and should be revised and updated based on production experience and the advancement of technology. Although every process is different, FDA's good manufacturing practice requirements implicitly require that manufacturers of similar products should meet a mini- mum, common standard of quality. The result of one company's adverse safety event (or development of a process de- signed to prevent such an event) may provide an opportunity to improve the safety of the entire industry. In this re- gard, trade associations that facilitate in- formation exchange add value. Similarly, auditing strategies can serve as a safeguard to ensure that a product is manufactured safely and efficiently. Au- dits provide oversight to a manufactur- ing process and give valuable feedback to the business, as well as assurance to customers. The frequency and type of audit, whether internal (conducted by one's own employees) or external (con- ducted by a third party), will vary based on the nature of the product, the risk posed from the intended or reasonably foreseeable use and the nature and de- gree of regulatory oversight. Internal auditing lets a business re- view and revise SOPs continuously based on the nature and characteristics of the finished product. Internal audi- tors also bring an inherent knowledge of the product to the review, allowing for a highly detailed analysis of a specific process or procedure. Conversely, external auditors pro- vide a critical degree of objectivity and neutrality with respect to a process. Ex- ternal auditing strategies often are used as an initial starting point to identify processes and procedures that pose risks or relevant considerations that may not be immediately apparent to an inter- nal auditor. The external auditor also might be able to leverage familiarity with best practices used throughout the industry to recommend changes or im- provements to a company's product or process. Similarly, the external auditor can rely upon his or her experience with regulatory agencies, such as the FDA, when recommending specific actions. Companies that are regulated by the FDA should consider best practices that do two essential things: Ensure compli- ance during normal production activities and help the company respond to adverse events. The latter is often mitigated by the designation of specific individuals who have the authority to make "com- mand decisions" regarding production, inspection, quality, health and safety. Companies that most effectively respond to unforeseen events implement strate- gies such as a tiered response system, an internal and external communications policy and the designation of a "go team" of legal, technical and executive partici- pants that can react quickly to FDA-re- lated incidents and investigations. Common sense prevails Ultimately, within the context of good manufacturing practice, common sense prevails. Developing and relying upon written procedures creates the benchmark com- panies use to measure planning, produc- tion and auditing activities. Machinery and processes are imperfect and consis- tently require review, revision, mainte- nance and updating. The evolution of technology and best practices also plays a critical role in defining the state of the industry. Similarly, human error is a fact of life that should be acknowledged but mini- mized to the extent possible. Generally speaking, the less opportunity for "cre- ative intervention" by employees, the lower the likelihood that human error will cause a GMP issue. Therefore, it is